CLEARFIL™ DC CORE PLUS

GUDID EKUR001029KA1

Guide tip (L)

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR001029KA1
• NIH Device Record Key: 515995db-e49b-44f5-9edb-f3cd148df66a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ DC CORE PLUS
• Version Model Number: #1029-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR001029KA0 [Unit of Use]
HIBCC	EKUR001029KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111982

FDA Product Code

• EBF: Material, Tooth Shade, Resin
• EID: Syringe, Restorative And Impression Material

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

• EKUR1259755KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 A1 C
• EKUR1259775KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 A2 C
• EKUR1259795KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 B1 C
• EKUR1259805KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 C1 C
• EKUR1259815KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 D2 C
• EKUR1259825KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 EW0 C
• EKUR1259845KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 NW C
• EKUR000967KA0 - Disposable brush tips (black): 2025-09-01